Pfenex Inc. (NYSE American: PFNX), today announced the appointment of Robert Peach, Ph.D. to the Pfenex Scientific Advisory Board. “We are very excited to have Dr. Peach join our Scientific Advisory Board and look forward to his insight and contributions as we leverage our Pfēnex Expression Technology platform to expand our development pipeline,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “I am looking forward to working with the innovative team at Pfenex and the rest of the Scientific Advisory Board on their efforts to expand their development pipeline leveraging the Pfēnex Expression Technology platform.

Pfenex Inc. (NYSE American: PFNX) a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to improve protein therapies for unmet patient needs, today announced the expiration of the 45-day period for Eli Lilly & Co. (“Lilly”) to file a lawsuit under the Hatch-Waxman Act and stay the approval of PF708 for 30 months. In addition, Pfenex is developing hematology/oncology products, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology, in collaboration with Jazz Pharmaceuticals.

Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to improve protein therapies for unmet patient needs, today announced the appointment of Martin B. Brenner, DVM, Ph.D., as its Chief Scientific Officer (CSO), effective immediately. “We are pleased to have Dr. Brenner join the Pfenex team at such an important time in the Company’s history. Martin’s experience identifying active modalities and therapies will make him a valuable new member of our executive team as we look to create value for our shareholders via new pipeline candidates,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.

Pfenex Inc. (NYSE American: PFNX) today announced that Serum Institute of India Private Limited (SIIPL), has completed a pivotal Phase 3 study for Pneumosil® a 10-valent pneumococcal conjugate vaccine, in which Serum Institute indicates all primary and secondary objectives were met. Pneumosil contains the recombinant carrier protein CRM197 produced by Serum Institute under a license to the Pfēnex Expression Technology®. Following review of the Complete Study Report and product dossier by the Drug Controller General of India (DCGI), Serum Institute has received an export license for Pneumosil.

Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to improve protein therapies for unmet patient needs, today announced the appointment of Magda Marquet, Ph.D. to its Board of Directors, February 28, 2019. Dr. Marquet was also appointed to serve as a member of the corporate governance and nominating committee. “We are pleased to welcome Dr. Marquet to the Pfenex Board.

Pfenex Inc. (NYSE American: PFNX) and Alvogen Ltd. today announced entering into agreements expanding their collaboration to develop and commercialize Pfenex’s lead product candidate, PF708, a proprietary teriparatide therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®/Forsteo®, to the EU, to certain countries in Middle East and North Africa (MENA) the ROW territories (the latter defined as all countries outside of the EU, US and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). This collaboration leverages Alvogen’s established international experience and expertise in regulatory, IP and supply chain activities, as well as its established network of specialty marketing and sales pharmaceutical companies in these regions.

Pfenex Inc. (NYSE American: PFNX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the 505(b)(2) New Drug Application (NDA) for the Company’s lead product candidate, PF708, a Forteo® therapeutic equivalent in the treatment of osteoporosis, which achieved $1.6 billion in global product sales in 2018. The acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review by the FDA.

Pfenex Inc. (NYSE American: PFNX) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of PF708 for the treatment of osteoporosis. The application is submitted as a 505(b)(2) NDA and references Eli Lilly and Company’s Forteo® (teriparatide) as the Reference Listed Drug.